Duloxetine Delayed-Release Capsules — Class III drug recall D-1435-2016
Terminated recall by Apotex Scientific, Inc, reported 2016-07-20, distributed nationwide. Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
| Recall number | D-1435-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Scientific, Inc, Arlington, TX, United States |
| Recall initiated | 2016-01-26 |
| Classified | 2016-07-14 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2022-06-15 |
| Distributed | Nationwide (US) |
| Quantity | 107,880 |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00360505299560 |
| NDC | 60505-2995-06 |
| Lot numbers | KV9794, KV9795, KV9796, KX6278 |
| Expiration dates | 2016-04-30 |
Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
Reason for recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1435-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.